Job Description
Our Client is looking for a Manager Quality Assurance ? QA Operations External Bio DS & DP to be based in Dublin,
The QA Manager will work in the QA Operations External Biologics DS & DP in the Quality Assurance Department. This unit oversees Qualified Person function, contract manufacturing operations, supply chain operations and supplier quality functions performed. The QA Manager will be responsible for the QA management of EU contract manufacturers, suppliers and test labs as applicable. This position will have direct reports.
Responsibilities:
The QA Manager is responsible for the management & control of EU/US contract manufacturers, suppliers and QC laboratories (as applicable) in compliance with applicable standards of GMP & GDP. The QA Manager will receive assignments in the form of goals.
Responsible for QA Oversight of CMOs, Suppliers, QC Labs
Responsible for the compliant day to day management of CMOs & resolution of all quality related issues.
Leading meetings with external parties and representing in professional manner.
Attendance at all weekly/ monthly and quarterly CMO meetings.
Represent management in meetings and cross functional teams.
QA support and management approval of all CMO documentation.
Development & assessment of quality metrics, CMO trending, KPIs and reports. Responsible to recommend actions as a result of such reviews / reports.
Management of critical issues and timely resolution, developing solutions to complex problems.
Proactive monitoring the performance of CMOs & suppliers to ensure that they remain in a state of control & implementing necessary improvements.
Leading, reviewing and approval of deviations, change controls which are related to CMO management.
Manager oversight and approval on all applicable quality systems pertaining to CMO management including but not limited to Deviations, Change Controls, CAPAs.
Management of annual vendor assessments
Leading or supporting CMO / Quality projects
Leading audits (external)
Support internal and regulatory agency inspections
Analysis of CMO management processes, development of quality improvement plans and continuous improvement.
Update and compliant management of CMO TQAs to ensure agreements are current and within date.
Review and approval of CMO Annual Product Quality Reviews
Roll out of training on QA procedures
Support validation activities related to CMO?s/ CTL?s as required
Support investigations into complaints
Support product launches activities associated with CMO?s/CTL?s/ Suppliers
Providing escalation, weekly updates, reports and stats to management as required.
EDUCATION AND EXPERIENCE REQUIRED
Bachelor?s degree in pharmacy, chemistry, biotechnology or a related discipline.
Extensive experience working in a QA role in the pharmaceutical industry.
DS and DP biologics manufacturing experience
Thorough understanding of quality systems, cGMPs, GDPs.
Experience in sterile biologics manufacturing
Experience in cell culture, fermentation and purification
Excellent interpersonal skills and professional skills
Flexible and comfortable with change
Able to prioritse and multitask in an environment with changing priorities.
Able to travel up to 20%
Advanced degree
Project management/ Lean / OE experience
Experience working with multiple sites/ locations
Experience working with contract manufacturing
Experience interfacing with regulatory bodies or working on regulatory submissions
Lead Auditor
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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